Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Attention-Deficit/Hyperactivity Disorder Clinical Trial

Official title:

A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640185
• Other study ID #: M10-346
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2008
• Last updated: January 10, 2013
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Have voluntarily signed an informed consent form.

• Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.

• Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.

• Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.

• Male subjects must agree to comply with applicable contraceptive requirements.

• Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.

Exclusion Criteria:

• Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.

• Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.

• Subject has a history of, or ongoing, serious medical problem.

• Subject has a history of significant allergic reaction to any drug.

• Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.

• Subject requires ongoing treatment with any psychiatric medication.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
• Placebo
Subjects will take one or two placebos once daily for the duration of the study.

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 7550	Bellevue	Washington
United States	Site Reference ID/Investigator# 7554	Eugene	Oregon
United States	Site Reference ID/Investigator# 7552	Farmington Hills	Michigan
United States	Site Reference ID/Investigator# 7551	Jacksonville	Florida
United States	Site Reference ID/Investigator# 7546	Lafayette	California
United States	Site Reference ID/Investigator# 7555	Memphis	Tennessee
United States	Site Reference ID/Investigator# 7553	Orlando	Florida
United States	Site Reference ID/Investigator# 7545	Overland Park	Kansas
United States	Site Reference ID/Investigator# 7547	Portland	Oregon
United States	Site Reference ID/Investigator# 7631	Seattle	Washington
United States	Site Reference ID/Investigator# 7548	Troy	Michigan
United States	Site Reference ID/Investigator# 7549	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAARS: Inv Total Score		Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56	No
Secondary	CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self		Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56	No
Secondary	TASS, AAQoL, WPAI		Day -1, Day 28, Day 56	No
Secondary	BRIEF-A, FTND		Day-1, Day 56	No
Secondary	QSU-Brief, Number of Cigarettes smoked per day		Day -1, Day 7, Day 14, Day 28, Day 42, Day 56	No